Access chamber and markers for biopsy device

ABSTRACT

A marker deployment tool may comprise a marker cannula having a lateral deployment aperture, a push rod slidably disposed within the marker cannula and a scalloped tip coupled to the distal end of the marker cannula. The scalloped tip may have a push rod recess configured to receive a portion of the distal end of the push rod such that the push rod does not appreciably extend out of the lateral deployment aperture when the push rod is actuated distally. The marker deployment tool may further comprise a magnet at or near the distal end. This magnet may be used in combination with a magnet or plurality of magnets disposed about an access chamber in a tissue sample holder to assist the user in aligning the marker deployment tool. The access chamber in the tissue sample holder may also include a valve, two valves, or a removable plug.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.14/568,488, filed Dec. 12, 2014 (now U.S. Pat. No. 9,370,402 issued Jun.21, 2016), which is a Continuation of U.S. patent application Ser. No.13/205,189, filed Aug. 8, 2011 (now U.S. Pat. No. 8,938,285 issued Jan.20, 2015). The disclosures of the priority applications are incorporatedin their entirety herein by reference.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under simple visual guidance, palpatory guidance, stereotacticguidance, ultrasound guidance, MRI guidance, PEM guidance, BSGIguidance, or otherwise. For instance, some biopsy devices may be fullyoperable by a user using a single hand, and with a single insertion, tocapture one or more biopsy samples from a patient. In addition, somebiopsy devices may be tethered to a vacuum module and/or control module,such as for communication of fluids (e.g., pressurized air, saline,atmospheric air, vacuum, etc.), for communication of power, and/or forcommunication of commands and the like. Other biopsy devices may befully or at least partially operable without being tethered or otherwiseconnected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRICompatible Surgical Biopsy Device,” published Jun. 12, 2003; U.S. Pub.No. 2006/0074345, entitled “Biopsy Apparatus and Method,” published Apr.6, 2006; U.S. Pub. No. 2007/0118048, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” published May 24, 2007; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Pub. No. 2009/0171242, entitled “Clutch andValving System for Tetherless Biopsy Device,” published Jul. 2, 2009;U.S. Pub. No. 2010/0152610, entitled “Hand Actuated Tetherless BiopsyDevice with Pistol Grip,” published Jun. 17, 2010; U.S. Pub. No.2010/0160819, entitled “Biopsy Device with Central Thumbwheel,”published Jun. 24, 2010; U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010; U.S. patent application Ser. No. 12/953,715, entitled “HandheldBiopsy Device with Needle Firing,” filed Nov. 24, 2010; U.S. patentapplication Ser. No. 13/086,567, entitled “Biopsy Device with MotorizedNeedle Firing,” filed Apr. 14, 2011; U.S. patent application Ser. No.13/099,497, entitled “Biopsy Device with Manifold Alignment Feature andTissue Sensor,” filed May 3, 2011; and U.S. patent application Ser. No.13/150,950, entitled “Needle Assembly and Blade Assembly for BiopsyDevice,” filed Jun. 1, 2011. The disclosure of each of the above-citedU.S. patents, U.S. patent application Publications, and U.S.Non-Provisional patent applications is incorporated by reference herein.

In some settings, it may be desirable to mark the location of a biopsysite for future reference. Moreover, it may be preferable to be able toaccess the biopsy site while the biopsy device is still located withinthe patient to accurately mark the biopsy site. Accordingly, one or moremarkers may be deposited at a biopsy site before, during, or after atissue sample is taken from the biopsy site.

In some instances, biopsy devices have been adapted to allow for markingfrom a side-entry into the biopsy probe. Depending upon the location ofthe access point and the clearance through the device, the markerdeployment device may be a flexible, semi-rigid, or a rigid deploymentdevice. Some merely exemplary marker deployment tools include theMAMMOMARK™, MICROMARK®, and CORMARK™ brand devices from Devicor MedicalProducts, Inc. of Cincinnati, Ohio. Further exemplary devices andmethods for marking a biopsy site are disclosed in U.S. Pub. No.2009/0209854, entitled “Biopsy Method,” published Aug. 20, 2009; U.S.Pub. No. 2009/0270725, entitled “Devices Useful in Imaging,” publishedOct. 29, 2009; U.S. Pub. No. 2010/0049084, entitled “Biopsy MarkerDelivery Device,” published Feb. 25, 2010; U.S. Pub. No. 2011/0071423,entitled “Flexible Biopsy Marker Delivery Device,” published Mar. 24,2011; U.S. Pub. No. 2011/0071424, entitled “Biopsy Marker DeliveryDevice,” published Mar. 24, 2011; U.S. Pub. No. 2011/0071391, entitled“Biopsy Marker Delivery Device with Positioning Component,” publishedMar. 24, 2011; U.S. Pub. No. 2011/0071431, entitled “Biopsy MarkerDelivery Device,” published Mar. 24, 2011; U.S. Pat. No. 6,228,055,entitled “Devices for Marking and Defining Particular Locations in BodyTissue,” issued May 8, 2001; U.S. Pat. No. 6,371,904, entitled“Subcutaneous Cavity Marking Device and Method,” issued Apr. 16, 2002;U.S. Pat. No. 6,993,375, entitled “Tissue Site Markers for In VivoImaging,” issued Jan. 31, 2006; U.S. Pat. No. 6,996,433, entitled“Imageable Biopsy Site Marker,” issued Feb. 7, 2006; U.S. Pat. No.7,044,957, entitled “Devices for Defining and Marking Tissue,” issuedMay 16, 2006; U.S. Pat. No. 7,047,063, entitled “Tissue Site Markers forIn Vivo Imaging,” issued May 16, 2006; U.S. Pat. No. 7,229,417, entitled“Methods for Marking a Biopsy Site,” issued Jun. 12, 2007; and U.S. Pat.No. 7,465,279, entitled “Marker Device and Method of Deploying a CavityMarker Using a Surgical Biopsy Device,” issued Dec. 16, 2008. Thedisclosure of each of the above-cited U.S. patents and U.S. patentapplication Publications is incorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements. In thedrawings some components or portions of components are shown in phantomas depicted by broken lines.

FIG. 1 depicts a perspective view of an exemplary biopsy device showingan exemplary probe coupled to an exemplary holster;

FIG. 2 depicts a perspective view of an exemplary biopsy device showingan exemplary probe decoupled from an exemplary holster;

FIG. 3 depicts a cross-sectional view of an exemplary tissue sampleholder;

FIG. 4 depicts a perspective view of an exemplary rotatable manifold;

FIG. 5 depicts a cross-sectional view of an exemplary tissue sampleholder having an inner valve and an outer valve and coupled to a probe;

FIG. 6 depicts a cross-sectional view of an exemplary alternative tissuesample holder having a single valve;

FIG. 7 depicts a cross-sectional view of yet another exemplary tissuesample holder and an exemplary removable plug;

FIG. 8 depicts a partial cross-sectional view of the tissue sampleholder of FIG. 7 with an exemplary luer check valve;

FIG. 9 depicts a top view of an exemplary tray for use with a rotatablemanifold of a tissue sample holder;

FIG. 10 depicts a side view of an exemplary marker deployment tool;

FIG. 11 depicts an enlarged perspective view of an exemplary scallopedtip of the exemplary marker deployment tool of FIG. 10;

FIG. 12 depicts an enlarged perspective view of an exemplary alternativescalloped tip;

FIG. 13 depicts an alternative enlarged view of an exemplary markerdeployment tool having a magnet; and

FIG. 14 depicts a rotatable manifold with complementary magnets.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

1. Overview of Exemplary Biopsy Device

FIG. 1 shows an exemplary biopsy device (10). Biopsy device (10)comprises a probe (20) and a holster (30). Probe (20) has a needle (40)that extends distally from a casing (80) of probe (20) and is insertableinto a patient's tissue to obtain tissue samples, as will be describedbelow. Biopsy device (10) further comprises a tissue sample holder (100)into which the tissue samples are deposited. By way of example only,probe (20) may be a disposable component and holster (30) may be areusable component to which probe (20) may be coupled, as shown in FIG.2. Use of the term “holster” herein should not be read as requiring anyportion of probe (20) to be inserted into any portion of holster (30).Indeed, in one configuration for biopsy device (10), probe (20) maysimply be positioned atop holster (30). Alternatively, a portion ofprobe (20) may be inserted into holster (30) to secure probe (20) toholster (30). In yet another version, a portion of holster (30) may beinserted into probe (20). Further still, probe (20) and holster (30) maybe integrally formed as a single unit. In versions where probe (20) andholster (30) are separable members, a port and/or a seal may be providedon holster (30) to couple with a second port and/or a second seal onprobe (20) such that the vacuum produced by a vacuum pump coupled toholster (30) may be fluidly connected to probe (20). Indeed, in onemerely exemplary version, the vacuum pump induces a vacuum within needle(40) as will be described in more detail below. The vacuum pump may becoupled by vacuum tubes to appropriate ports on biopsy device (10).Other suitable structural and functional combinations for probe (20) andholster (30) will be apparent to one of ordinary skill in the art inview of the teachings herein.

II. Exemplary Probe

As described above, probe (20) has a needle (40) extending distally fromprobe (20) and a tissue sample holder (100) coupled to a proximal end ofprobe (20).

A. Exemplary Bubble Level

In certain situations, it may be desirable for a user to align or keepbiopsy device (10) level during a procedure. One merely exemplarysituation may occur during a MR biopsy when using a targeting grid withbiopsy device (10). Merely exemplary biopsy device grids are disclosedin U.S. patent application Ser. No. 12/485,119, entitled “BiopsyTargeting Cube with Elastomeric Edges,” filed Jun. 16, 2009; U.S. patentapplication Ser. No. 12/485,138, entitled “Biopsy Targeting Cube withElastomeric Body,” filed Jun. 16, 2009; U.S. patent application Ser. No.12/485,168, entitled “Biopsy Targeting Cube with Malleable Members,”filed Jun. 16, 2009; U.S. patent application Ser. No. 12/485,278,entitled “Biopsy Targeting Cube with Angled Interface,” filed Jun. 16,2009; and U.S. patent application Ser. No. 12/485,318, entitled “BiopsyTargeting Cube with Living Hinges,” filed Jun. 16, 2009. The disclosureof each of the above-cited U.S. patent applications is incorporated byreference herein. When utilizing one of these exemplary grids, it may beuseful to keep biopsy device (10) level to properly target a tissuelesion for sampling. For instance, by maintaining biopsy device (10)level with one of the exemplary grids, the accuracy of targeting alesion may be increased by reducing the possibility of tilting whileinserting biopsy device (10) into the patient's tissue. Accordingly, aleveling device for biopsy device (10) may be useful to the user duringsuch situations.

Casing (80) of the present example may comprise a leveling device (86)coupled to an outer surface (82) of casing (80). In the example shown inFIG. 1, leveling device (86) is shown as a bulls eye bubble levelattached to the top of outer surface (82) of casing (80), though itshould be understood that the present configuration is merely exemplary.Indeed, leveling device (86) may alternatively comprise a single tubularbubble level, a pair of orthogonal tubular bubble levels, or any othersuitable leveling device (86) as will be apparent to one of ordinaryskill in the art in view of the teachings herein. In some situationswhere two orthogonal tubular bubble levels are utilized, a first tubularbubble level may be attached to a side of outer surface (82) while thesecond tubular bubble level may be attached to a proximal end of outersurface (82). In this configuration, the first tubular bubble level isconfigured to determine whether biopsy device (10) is longitudinallylevel and the second tubular bubble level is configured to determinewhether biopsy device (10) is laterally level. Alternatively, in theversion having the bulls eye bubble level shown in FIG. 1, the singlebulls eye level is configured to determine whether biopsy device (10) isboth longitudinally and laterally level. Furthermore, leveling device(86) may be integrated into casing (80), adhesively attached to outersurface (82), detachably coupled to outer surface (82), or coupled tocasing (80) in any other suitable method as will be apparent to one ofordinary skill in the art in view of the teachings herein. In yet afurther alternative, leveling device (86) may be coupled to holster(30), tissue sample holder (100) or needle (40) to indicate when biopsydevice (10) is longitudinally and/or laterally level.

While some merely exemplary configurations for casing (80) have beendescribed, other equally suitable configurations will be apparent to oneof ordinary skill in the art in view of the teachings herein.

B. Exemplary Needle for Exemplary Probe

Needle (40) of the present example includes a cannula (42), a distal tip(44), and a lateral aperture (46) proximal to distal tip (44). Distaltip (44) shown in FIGS. 1-2 is configured to pierce and penetrate tissuewithout requiring a high amount of force or requiring an opening to bepre-formed in the tissue prior to insertion of distal tip (44), thoughit should be understood that distal tip (44) may have other suitableconfigurations, including a blunt tip. Distal tip (44) may comprise ablade assembly for coupling a flat blade to cannula (42), such as theone described in U.S. patent application Ser. No. 13/150,950, entitled“Needle Assembly and Blade Assembly for Biopsy Device,” filed Jun. 1,2011, the disclosure of which is incorporated by reference herein. Yetother equally suitable configurations for distal tip (44) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Needle (40) of the present example is also coupled to a pair ofindicators (72) shown within indicator windows (70) of casing (80).Indicators (72) may be rotatable drums having a plurality of markings,such as numbers, letters, and/or colors, to provide an indication to auser of the orientation of needle (40). In the present example,indicators (72) are coupled to gears that mesh with a complementary gearon a proximal portion of needle (40) such that when needle (40) isrotated about its longitudinal axis, either through a user using athumbwheel or by a motor, indicators (72) then rotate as well. In onemerely exemplary version, indicators (72) may be aligned and have aplurality of markings to indicate the o'clock position of lateralaperture (46). In an alternative version, indicators (72) may indicatethe orientation of distal tip (44). Still further configurations forindicators (72) will be apparent to those of ordinary skill in the artin view of the teachings herein.

Needle (40) may further be divided into a first lumen (94) and a secondlumen (96). One such exemplary configuration for needle (40) isdescribed in U.S. patent application Ser. No. 13/150,950, entitled“Needle Assembly and Blade Assembly for Biopsy Device,” filed Jun. 1,2011. In one version, needle (40) may be an ovular cross-sectional tubehaving a cut-out portion extending longitudinally from the distal end ofneedle (40) and terminating at a position proximal of the distal end.For example, the cut-out portion may extend longitudinally along theentire length of needle (40) or the cut-out portion may terminate at alongitudinal position less than the length of needle (40) and distal ofthe proximal end of needle (40). A circular cross-sectional tube may beattached where the cut-out portion was removed; the interior of thecircular cross-sectional tube defining a first lumen (94) and thecombination of the exterior of the circular cross-sectional tube and apartial section of needle (40) defining a second lumen (96) parallel tofirst lumen (94). Alternatively, a longitudinal wall (not shown) may beinserted into needle (40) and attached to the interior of needle (40).The top region of needle (40) and the longitudinal wall defining thefirst lumen (94) and the bottom region of needle (40) and thelongitudinal wall defining the second lumen (96). A plurality ofopenings may be formed within the longitudinal wall or the circularcross-sectional tube to permit fluid communication between first lumen(94) and second lumen (96). Still other suitable configurations forneedle (40) having a first lumen (94) and a second lumen (96) will beapparent to one of ordinary skill in the art in view of the teachingsherein.

Lateral aperture (46) is located proximally of distal tip (44) and issized to receive tissue when needle (40) is inserted into the tissue ofa patient. A tubular cutter (90) is disposed within first lumen (94) ofneedle (40) and is operable to rotate and/or translate relative toneedle (40) to sever tissue protruding through lateral aperture (46).Tubular cutter (90), as partially shown in FIG. 3, comprises a sharpdistal end and defines a cutter lumen (98) therein. In the presentexample, tubular cutter (90) is actuated by a motor, though it should beunderstood that tubular cutter (90) may be actuated by a variety ofmechanical or electromechanical components, such as a pneumatic system,a spring-loaded system, or any other suitable component. Tubular cutter(90) is configured to actuate between a distal-most position, in whichtubular cutter (90) substantially blocks access through lateral aperture(46) resulting in a “closed” lateral aperture (46), and a proximal-mostposition, in which a distal end of tubular cutter (90) is proximal to aproximal edge of lateral aperture (46) resulting in an “open” lateralaperture (46). Thus, when lateral aperture (46) is in an “open”position, tissue may be drawn through lateral aperture (46) and intocannula (42), thereby permitting tubular cutter (90) to be advanceddistally to sever a tissue sample with the sharp distal end.Additionally, while lateral aperture (46) is in an “open” position,items from within cannula (42) or elsewhere within biopsy device (10)may be expelled out through lateral aperture (46) and into the tissue ofa patient or into a cavity formed after a tissue sample has beenremoved. Merely exemplary items that may be expelled through lateralaperture (46) include medication, saline, portions of other medicaldevices, biopsy site markers, or any other suitable item as will beapparent to one of ordinary skill in the art in view of the teachingsherein.

When biopsy device (10) is operated, second lumen (96) may be configuredto selectively provide atmospheric air, vacuum and/or saline to cutterlumen (98). The plurality of openings described above may be arrangedsuch that at least one opening is located at a longitudinal positionthat is distal to the distal edge of lateral aperture (46) such thatcutter lumen (98), first lumen (94), and second lumen (96) remain influid communication even when tubular cutter (90) is advanced to thedistal-most position. In one merely exemplary operational mode, when atissue sample is severed by tubular cutter (90), a vacuum may be appliedto cutter lumen (98) while atmospheric air is provided through a ventfluidly coupled to first lumen (94) and/or second lumen (96). Thecombination of vacuum on one side of the tissue sample and atmosphericair on the other may cooperatively urge the tissue sample proximallythrough tubular cutter (90) and towards tissue sample holder (100).Alternatively, when no tissue samples are present within needle (40),saline may be flushed through cutter lumen (98), first lumen (94), andsecond lumen (96) to clear any debris within. A valve assembly may beprovided in probe (20) or holster (30) to selectively change between thevarious configurations. One such valve assembly may be constructed inaccordance with at least some of the teachings of U.S. Pub. No.2010/0317997, entitled “Tetherless Biopsy Device with Reusable Portion,”published Dec. 16, 2010; in accordance with the teachings of U.S. patentapplication Ser. No. 12/953,715, entitled “Handheld Biopsy Device withNeedle Firing,” filed Nov. 24, 2010; and/or otherwise. Alternatively, inthe present example, a separate control module can be provided that hasinternal controls to selectively apply vacuum, saline, and/oratmospheric air. One such control module may be constructed inaccordance with at least some of the teachings of U.S. Pub. No.2010/0160817, entitled “Control Module Interface for MRI Biopsy Device,”published Jun. 24, 2010. Other suitable alternative versions, features,components, configurations, and functionalities of needle (40) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

C. Exemplary Tissue Sample Holder

In some situations it may be useful to have access to the cutter lumen,first lumen, and/or lateral aperture of a biopsy device. As discussedabove, this access may be desirable to expel items out through thelateral aperture into a patient's tissue or into a cavity formed in thetissue after excising a biopsy sample. Merely exemplary items that maybe expelled include medication, saline, portions of other medicaldevices, biopsy site markers, or any other suitable item. In certainsituations, the only accessible portion of a biopsy device may be theproximal end of the device. Accordingly, if a tissue sample holder iscoupled to the proximal end of the biopsy device, access through thetissue sample holder may be useful to expel one of the above-mentionitems. Moreover, it may also be preferable to provide selective accessthrough the tissue sample holder such that a vacuum can be providedprior to access to clear the biopsy device of debris. Furthermore, byproviding selective access through the tissue sample holder, the usermay not need to remove and reattach the tissue sample holder each timeaccess is desired, thereby possibly preserving sterility and maintainingease of use of the device. Accordingly, providing a chamber within thetissue sample holder through which access to the cutter lumen, firstlumen, and/or lateral aperture is possible may be useful to a user of abiopsy device.

As seen in FIG. 3, an exemplary tissue sample holder (100) is detachablycoupled to the proximal end of probe (20). Tissue sample holder (100) ofthe present example is configured to receive tissue samples that aresevered by tubular cutter (90) and communicated proximally throughcutter lumen (98). Probe (20) of the present example comprises atransfer member (22) in fluid communication with cutter lumen (98)within needle (40) and a vacuum line (52) coupled to a vacuum pump. Inthe present example, transfer member (22) has a needle aperture (24) anda vacuum aperture (26). Transfer member (22) is configured toselectively connect needle (40) to a tray portion (158) of a selectedchamber (150) and selectively connect vacuum line (52) to a vacuumportion (156) of the selected chamber (150) such that vacuum line (52),selected vacuum portion (156), selected tray portion (158), and needle(40) are all in fluid communication. By way of example only, transfermember (22) may be made from a resilient material, such as rubber,synthetic rubbers (such as Neoprene), liquid silicone rubber,santoprene, or any other suitable material. Tissue sample holder (100)as shown in FIG. 3 further comprises one or more removable trays (400),an outer cover (120), and a rotatable manifold (140).

1. Exemplary Rotatable Manifold

Referring now to FIG. 4, rotatable manifold (140) comprises a pluralityof chambers (150) positioned about a central hub (142) where each of theplurality of chambers (150) extend through rotatable manifold (140). Inthe present example, thirteen chambers (150) are radially positionedabout central hub (142) with at least one chamber configured to be anaccess chamber (160) and as will be described in more detail below. Itshould be understood that more than thirteen or less than thirteenchambers (150) may be radially positioned about central hub (142).Central hub (142) is configured to couple to a portion of probe (20)such that rotatable manifold (140) may be rotated relative to probe(20). Rotatable manifold (140) may further comprise a distal flange(132) and a complementary slot (134) formed therein, as will bedescribed in more detail below.

As shown in FIG. 3, probe (20) of the present example comprises arotation member (110) configured to be insertable into a central recess(144) of central hub (142). By way of example only, rotation member(110) comprises a shaft (112) having a proximal end and a distal end, amanifold gear (114) attached to the distal end of shaft (112), a shaftrecess (116) extending distally from the proximal end, and a cross-slot(117), shown in FIG. 5, located at the proximal end of shaft (112). Inthe present version, shaft recess (116) is configured to receive amanifold shaft (146) and cross-slot (117) is configured to couple to aslot member (148) such that rotatable manifold (140) may be rotated whenmanifold gear (114) of rotation member (110) is rotated. Probe (20)further comprises a pawl (118) configured to selectively engage manifoldgear (114). Pawl (118) is configured to be biased towards manifold gear(114). When probe (20) is detached from holster (30), pawl (118)actuates to engage manifold gear (114) and inhibits rotation of rotationmember (110). Conversely, when probe (20) is coupled to holster (30),pawl (118) is disengaged from manifold gear (114) to permit rotation ofrotation member (110). One merely exemplary configuration to disengagepawl (118) is a tab extending outwardly from holster (30).

Still referring to FIG. 3, central recess (144) is configured to receivea portion of shaft (112) while manifold shaft (146) is inserted intoshaft recess (116) and cross-slot (117) is coupled to slot member (148).Pawl (118) may retain rotation member (110) in a stationary positionwhile shaft recess (116), cross-slot (117), manifold shaft (146) andslot member (148) are aligned. As a result of this alignment, a selectedchamber (150) of rotatable manifold (140) is aligned with needleaperture (24) of transfer member (22). In addition, this alignment maypermit biopsy device (10) to keep track of the orientation of tissuesample holder (100) either electronically (such as with a control boardand appropriate programming) or mechanically (such as with a numbereddisc, drum, or other physical member with markings) even while changingbetween different tissue sample holders (100). With tissue sample holder(100) coupled to probe (20), rotatable member (110) is operable torotate rotatable manifold (140) utilizing the engagement of shaft recess(116), cross-slot (117), manifold shaft (146), and slot member (148).Additionally, an alignment pin recess (not shown) may be included on thedistal end of rotatable manifold (140) to engage an alignment pinextending from the proximal end of probe (20), such as that disclosed inU.S. patent application Ser. No. 13/099,497, entitled “Biopsy Devicewith Manifold Alignment Feature and Tissue Sensor,” filed May 3, 2011,the disclosure of which is incorporated by reference herein. Thealignment pin may be configured to translate proximally in response toproximal movement of cutter (90) and, if rotatable manifold (140) isproperly aligned, the alignment pin enters alignment pin recess.Alignment pin recess may be configured to be a longitudinal conicalfunnel such that if rotatable manifold (140) is slightly askew, then theproximal movement of the alignment pin may engage the sidewalls of theconical funnel to adjust the alignment of rotatable manifold (140). Ofcourse, other equally suitable configurations for alignment pin andalignment pin recess will be apparent to those of ordinary skill in theart in view of the teachings herein.

i. Exemplary Chambers

As mentioned above, FIG. 4 depicts a plurality of chambers (150)radially positioned about central hub (142). Rotatable manifold (140) isrotatable such that each chamber (150) may be selectively aligned withneedle aperture (24) and vacuum aperture (26). Chambers (150) of thepresent example are partial pie-shaped chambers extending substantiallythrough rotatable manifold (140), though it should be understood thatchambers (150) may have other configurations. Merely exemplaryalternative chambers (150) include circular chambers, square chambers,triangular chambers, or any other suitable shape. Chambers (150) mayalso extend only partially through rotatable manifold (140) instead ofcompletely through. Moreover, as in the present example, a portion ofchamber (150) may extend completely through rotatable manifold (140)while a second portion does not. Chambers (150) are separated by aplurality of walls (152) such that each chamber (150) is substantiallyin fluid isolation relative to every other chamber (150). Each wall(152) comprises a pair of ledges (154) extending longitudinally alongeach chamber (150) and outwardly from wall (152). Ledges (154) areconfigured to support tissue sample containers (450), shown in FIGS. 3and 9, of removable trays (400), as will be described later herein. Theinteriors of chambers (150) are divided into a vacuum portion (156) anda tray portion (158). Vacuum portion (156) is defined by the portion ofchamber (150) located between central hub (142) and ledges (154). Trayportion (158) is defined by the portion of chamber (150) located betweenledges (154) and an outer edge (180) of rotatable manifold (140).

In one merely alternative version, a wall may be inserted into eachchamber (150) where ledges (154) protrude, there by physically definingvacuum portion (156) and tray portion (158). In yet a furtheralternative, the wall may be integrally formed in rotatable manifold(140). The wall in this version may include a plurality of openings topermit fluid communication between tray portion (158) and vacuum portion(156). In yet a further version, a proximal wall may be formed at theproximal end of each chamber (150). A length of vacuum portion (156) mayextend vertically into this proximal wall and the proximal wall maycomprise a plurality of openings such that the proximal end of trayportion (158) is in fluid communication with vacuum portion (156).Vacuum portion (156) may also be omitted entirely or vacuum portion(156) may be located elsewhere on rotatable manifold (140).

Further still, in another version, rotatable manifold (140) may includea disc with a plurality of radially outwardly extending chambers (150).Further still, rotatable manifold (140) may instead be a translatablelinear manifold that includes vertical and/or horizontal chambers (150),or, in yet a further version, a matrix of chambers (150) may be providedin a rectangular manifold. Of course other configurations for rotatablemanifold (140) will be apparent to one of ordinary skill in the art inview of the teachings herein.

ii. Exemplary Access Chamber Configurations

At least one chamber of the plurality of chambers (150) is configured tobe an access chamber (160). Access chamber (160) of the present exampleis configured differently from the other chambers (150), though itshould be understood that this is merely optional. In the presentexample, access chamber (160) comprises a tubular chamber extendingthrough rotatable manifold (140) and having recessed portions (162) atthe distal and proximal ends that are configured to receive valvemembers (164, 166). In one merely exemplary version shown in FIG. 5,access chamber (160) comprises an inner valve (164) and an outer valve(166). Inner valve (164) is located substantially at the distal end ofaccess chamber (160) and outer valve (166) is located substantially atthe proximal end of access chamber (160). Inner valve (164) may beconfigured to be a variety of different valve types, including duckbillvalves, domed valves, cross-slit valves, domed cross-slit valves, and/orany other suitable valve or combination of valves as will be apparent toone of ordinary skill in the art in view of the teachings herein. Innervalve (164) and/or recessed portion (162) may further be configured tohave a recessed distal face such that needle aperture (24) and vacuumaperture (26) of transfer member (22) may be in direct fluidcommunication distally of inner valve (164) when access chamber (160) isaligned with transfer member (22). In this alignment, if a vacuum isapplied by a vacuum pump, a vacuum path is formed from first lumen (94),through cutter lumen (98), through needle aperture (24) of transfermember (22), and through vacuum aperture (26) to the vacuum pump.Accordingly, when the vacuum pump is activated and access chamber (160)is so aligned, first lumen (94), cutter lumen (98), needle aperture (24)and vacuum aperture (26) may be cleared of any debris while inner valve(164) isolates access chamber (160) from the vacuum. Additionally,saline, a combination of saline and vacuum, a medicinal drug, or anyother suitable fluid may be applied along the same path while accesschamber (160) is fluidly isolated.

Outer valve (166) may be the same type of valve as inner valve (164) orouter valve (166) may be any other type of valve different from innervalve (164). Outer valve (166) provides a second, exterior seal foraccess chamber (160) to prevent objects from accidentally entering orexiting access chamber (160). An item may be inserted through outer andinner valves (166, 164), through needle aperture (24), through cutterlumen (98), through first lumen (94), and, optionally, out lateralaperture (46) to access the cavity where a biopsy sample was taken from.With this version, access to the biopsy site is permissible through theproximal end of biopsy device (10) while needle (40) is still insertedwithin the patient.

In an alternative version, shown in FIG. 6 access chamber (260) maycomprise a single valve (262) located at a point within access chamber(260). For example, single valve (262) may be located at thelongitudinal midpoint of access chamber (260). Single valve (262) may beconfigured to be a variety of different valve types, including duckbillvalves, domed valves, cross-slit valves, domed cross-slit valves, and/orany other suitable valve or combination of valves as will be apparent toone of ordinary skill in the art in view of the teachings herein. Withsingle valve (262) in place, a vacuum may be drawn by the vacuum pumpthrough needle (40) while access chamber (260) is aligned with needleaperture (24) without losing much, if any, vacuum through access chamber(260). Accordingly, cutter lumen (98), first lumen (94), and secondlumen (96) of needle (40) may be cleared of debris by the application ofvacuum while access chamber (260) is aligned. An item may be insertedthrough single valve (262), through needle aperture (24), through cutterlumen (98), through first lumen (94) and, if necessary, out lateralaperture (46) to access the cavity where a biopsy sample was taken from.Thus, access to the biopsy site is also permissible while needle (40) isstill inserted within the patient utilizing this alternative version. Ofcourse, with the aforementioned seals (164, 166, 262) may be overmoldedor integrally formed for each access chambers (160, 260).

Still yet another version for access chamber (360) includes a removableplug (300) as shown in FIG. 7. In this version, access chamber (360) isa chamber substantially similar to access chamber (260) except singlevalve (262) is omitted. Exemplary removable plug (300) comprises ahandle (310) and a shaft (320). Shaft (320) is sized to be insertableinto substantially the entire length of access chamber (360).Alternatively, shaft (320) may extend less than the entire length ofaccess chamber (360). Shaft (320) may further include at least oneannular sealing member (330) disposed about shaft (320) at a pointdistal of handle (310). In the example shown in FIG. 7, removable plug(300) has a resilient annular sealing member (330) disposed about shaft(320) at the distal end of shaft (320). Shaft (320) and resilientannular sealing member (330) may be made of a resilient material, suchas low-density polyethylene (LDPE). A plurality of resilient annularsealing members (330) may be disposed about shaft (320) at a pluralityof points distal of handle (310). Annular sealing member (330) mayalternatively be a flexible member that tapers as it extends outwardlyfrom shaft (320) to form a wiper-type seal. As with other componentsdescribed herein, shaft (320) and annular sealing member (330) may haveany other suitable configuration as will be apparent to one of ordinaryskill in the art in view of the teachings herein. Handle (310) is shownas a tab extending from shaft (320) having a flared portion at theproximal end. When removable plug (300) is inserted into access chamber(360), removable plug (300) substantially seals access chamber (360),thereby inhibiting fluid flow in to or out of biopsy device (10) throughaccess chamber (360). With removable plug (300) inserted, a vacuum maybe drawn by the vacuum pump while access chamber (360) is aligned withneedle aperture (24) without losing much, if any, vacuum through accesschamber (360). Accordingly vacuum aperture (26), needle aperture (24),cutter lumen (98), first lumen (94), and/or second lumen (96) may becleared of debris by the application of vacuum prior to accessing thetissue through lateral aperture (42) through access chamber (360).

A luer check valve (370) may alternatively be inserted into accesschamber (360), as shown in FIG. 8. Luer check valve (370) of the presentexample comprises a longitudinal passage (378), a seal (372) locatedsubstantially at a proximal end of luer check valve (370), a luer lockconnector (374) at a distal end of the luer check valve (370), and avalve (376) disposed within longitudinal passage (378). Seal (372) isshown as a rubber or silicone o-ring seal that may prevent fluid fromcommunicating proximally of seal (372) when luer check valve (370) isinserted into access chamber (360). Luer lock connector (374) comprisesa threaded portion for coupling to a complementary luer fitting. Valve(376) is disposed distally of luer lock connector (374) and isconfigured to substantially prevent fluids from entering or exitingthrough luer check valve (370) without applying some force to the fluid.When luer check valve (370) is inserted into access chamber (360), avacuum may be drawn by the vacuum pump while access chamber (360) isaligned with needle aperture (24) without losing much, if any, vacuumthrough access chamber (360). Accordingly vacuum aperture (26), needleaperture (24), cutter lumen (98), first lumen (94), and/or second lumen(96) may be cleared of debris by the application of vacuum prior tocoupling a syringe or other item via luer lock connector (374). By wayof example only, when a syringe is coupled to luer lock connector (374),a medicament contained within the syringe may be forced past valve (376)by depressing a plunger of the syringe. If needle aperture (24) is opento the tissue, the medicament may be applied to the tissue withoutremoving biopsy device (10). It should be understood that items otherthan medicaments may be injected to the tissue, including contrast dyes,saline, gels, or other suitable items that may be used as will beapparent to one of ordinary skill in the art in view of the teachingsherein. Of course, luer check valve (370) may alternatively beintegrated into rotatable manifold (140). Further still, luer checkvalve (370) may include a spring loaded luer valve. As with othercomponents described herein, luer check valve (370) will be apparent toone of ordinary skill in the art in view of the teachings herein.

2. Exemplary Removable Trays

One or more removable trays (400), shown in FIG. 9, are configured topermit a user to remove severed tissue samples from tissue sample holder(100) without having to decouple tissue sample holder (100) from probe(20). Each tray (400) comprises a main portion (410) and at least onetissue sample container (450). Each tray (400) may be rigid, and may bepreformed to correspond to the generally arcuate configuration ofrotatable manifold (140), or, alternatively, trays (400) may be formedof a flexible material, such that trays (400) may be bent or deformed toconform to the configuration of rotatable manifold (140). Further still,main portion (410) may be formed of a rigid material and coupled to aflexible material forming the at least one tissue sample container(450). Conversely, the at least one tissue sample container (450) may beformed of a rigid material while the main portion (410) comprises aflexible material. In the example shown in FIG. 9, each tray (400)comprises a main portion (410) and six tissue sample containers (450),though it should be understood that any number of tissue samplecontainers (450) may be used. Main portion (410) of the present examplecomprises one or more joints (420), such as living hinges, such thatparts of main portion (410) may bend or flex at joints (420). As shownin FIG. 9, each main portion (410) of trays (400) has two living hingejoints (420). Main portion (410) further comprises a handle (430) for auser to grip and maneuver tray (400). Handle (430) may be constructed ofa rigid material to not flex when gripped by a user carrying tray (400),and handle (430) may be located at the midpoint of main portion (410) ofeach tray (400).

Each tissue sample container (450) of the present example has a baseportion (452), a proximal end wall (454), a distal end wiper wall (455),and a pair of container sidewalls (456), defining a tissue samplecontainer (450). Tissue sample containers (450) may be integrally formedwith main portion (410), or tissue sample containers (450) may bemechanically or chemically bonded to main portion (410). Distal endwiper wall (455) is sized to substantially fill the area of each chamber(150) such that when tissue sample container (450) is removed fromrotatable manifold (140), distal end wiper wall (455) wipes bits oftissue off the walls of rotatable manifold (140). In the example shown,a plurality of offset members (440) offset proximal end walls (454) frommain portion (410), though it should be understood that this is merelyoptional and proximal end walls (454) may be directly coupled to mainportion (410). Plurality of offset members (440) may include wiper bladetype seals and may aid the sealing of the tissue sample container (450)when inserted into the rotatable manifold (140). By way of example only,each tissue sample container (450) is configured to receive a singletissue sample severed by tubular cutter (90). Alternatively, tissuesample containers (450) may be configured such that each tissue samplecontainer (450) may hold more than one tissue sample. Tissue samplecontainers (450) are configured to be insertable into chambers (150) ofrotatable manifold (140) for use with biopsy device (10). In the exampleshown, tissue sample containers (450) are inserted through the proximalend of rotatable manifold (140) into tray portion (158) and are locatedatop ledges (154). Base portion (452) has a plurality of openings (458)permitting fluid communication through tissue sample container (450)into vacuum portion (156) of chamber (150). Accordingly, when tissuesample containers (450) are inserted into chambers (150), first lumen(94), cutter lumen (98), and needle aperture (24) may be in fluidcommunication with vacuum line (52) through tissue sample container(450), openings (458), vacuum portion (156) and vacuum aperture (26).Thus, once a tissue sample is severed by tubular cutter (90), the tissuesample may be transported proximally by vacuum pressure produced by thevacuum pump until the tissue sample is within tissue sample container(450). After the tissue sample is stored within a tissue samplecontainer (450), rotatable manifold (140) may be rotated by rotatingmember (110) to align a new tissue sample container (450) with needle(40).

Each tray (400) may further comprise one or more types of markings orother indicia to distinguish one tissue sample container (450) fromanother tissue sample container (450). For instance, a number or otherdistinguishing marking may be provided on or near each tissue samplecontainer (450), such as in relief form, in recessed form, or otherwise.In the example shown, a number of distinguishing marks are provided onmain portion (410) proximal to each tissue sample container (450). Inanother embodiment, a radiopaque marker may be provided on or near eachtissue sample container (450). For instance, an entire tray (400) thatis carrying one or more tissue samples may be placed under X-ray forevaluation, and the radiopaque marker associated with each tissue samplecontainer (450) (and accordingly, associated with a corresponding tissuesample), may be visible in the image obtained using X-ray. In otherwords, the tissue samples may not need to be removed from trays (400) inorder to take an X-ray or radiograph image of the tissue samples.Furthermore, trays (400) may be dropped directly into formalin or anyother liquid with the tissue samples still contained within tissuesample containers (450). Other structures and techniques that may beused with trays (400) as will be apparent to those of ordinary skill inthe art in view of the teachings herein.

3. Exemplary Outer Cover

An outer cover (120) may also be provided with tissue sample holder(100), as shown in FIG. 3. Outer cover (120) comprises a distal couplingsection (122), a hollow cylindrical body (124), and an inwardlyextending proximal lip (126). Proximal lip (126) extends radiallyinwardly to substantially restrict rotatable manifold (140) from movingproximally along the longitudinal axis away from probe (20) when tissuesample holder (100) is coupled to probe (20). Distal coupling section(122) is configured to couple to a proximal end of probe (20). Merelyexemplary coupling configurations include frictional fit, tab and slot,clamps, clips, screws, bolts, integral threading, or any other suitablecoupling mechanism as will be apparent to one of ordinary skill in theart in view of the teachings herein. Additionally, a seal (28) may beprovided on the proximal end of probe (20) that may aid in sealing outercover (120) and/or rotatable manifold (140) when coupled to the proximalend of probe (20). Seal (28) of the present example comprises a rubbero-ring seal, but other equally suitable seals, including disc-type sealsor silicone caulk, may be used for seal (28). Hollow cylindrical body(124) is sized such that rotatable manifold (140) can rotate withinhollow cylindrical body (124) between proximal lip (126) and distalcoupling section (122) while outer cover (120) is couple to probe (20).Distal coupling section (122) may further comprise a tab extendinginward, and rotatable manifold (140) may comprise a complementary slot(134) formed in the distal flange (132) such that the tab may beinserted through slot (134) when inserting rotatable manifold (140) intoouter cover (120). Distal flange (132) of rotatable manifold (140)substantially restricts rotatable manifold (140) from moving distallyalong the longitudinal axis when the tab and slot (134) are not aligned.Accordingly, it will be appreciated that distal flange (132), the tab,and proximal lip (126) cooperatively retain rotatable manifold (140)within outer cover (120) by restricting longitudinal movement ofrotatable manifold (140) while still permitting rotational movement.Outer cover (120) may be made of a transparent material or a translucentmaterial such that rotatable manifold (140) may be seen within. In sucha situation, rotatable manifold may have a plurality of markings on theexterior of rotatable manifold to indicate each chamber (150, 160) ofrotatable manifold, or, in one alternative, only access chamber (160)may have a corresponding marking on rotatable manifold (140). In yet afurther alternative, outer cover (120) may be an opaque material.

In yet a further version, proximal lip (126) may be omitted and a pairof snap bosses (not shown) may be formed on a proximal end of rotatablemanifold (140). The snap bosses extend radially outward from rotatablemanifold (140) such that outer cover cannot translate proximally pastthe snap bosses. Such snap bosses may be located approximately 180degrees apart from each other on rotatable manifold (140), or such snapbosses may be at any other suitable location on rotatable manifold(140), including from one degree to 180 degrees, inclusive. Furthermore,a single snap boss may be provided or, in other instances, more than twosnap bosses may be provided. Of course other equally suitableconfigurations for outer cover (120) and rotatable manifold (140) willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

While various exemplary versions for tissue sample holder (100) havebeen described, still other suitable ways in which tissue sample holder(100) may be constructed and operable will be apparent to those ofordinary skill in the art in view of the teachings herein.

III. Exemplary Marker Applier

As shown in FIG. 10, an exemplary marker deployment tool (600) comprisesa marker cannula (610) having a distal end (612) and a lateraldeployment aperture (620). A biopsy site marker (650) is slidablydisposed within marker cannula (610). Marker deployment tool (600)further comprises a push rod (630) having a distal end located proximalof biopsy site marker (650). Push rod (630) is also slidably disposed inmarker cannula (610) and is operable to push biopsy site marker (650)out through the lateral deployment aperture (620), as shown in FIG. 10.Some merely exemplary marker deployment tools include the MAMMOMARK™,MICROMARK®, and CORMARK™ brand devices from Devicor Medical Products,Inc. of Cincinnati, Ohio.

A grip (640) may be coupled to marker cannula (610) and a plunger (644)may be coupled to push rod (630) such that marker deployment tool (600)may be manipulated by a single hand of a user to deploy biopsy sitemarker (650). For marker deployment tools (600) having a lateraldeployment aperture (620), it may be necessary to include a ramp-likestructure at or near the distal end of marker cannula (610) to redirectbiopsy site marker (650) out lateral deployment aperture (620). Ininstances where a relatively flexible marker deployment tool (600) isnecessary, marker cannula (610) and push rod (630) may be constructed ofrelatively flexible materials. Alternatively, marker cannula (610) andpush rod (630) may be constructed of relatively stiff materials.Furthermore, marker cannula (610) and push rod (630) may be constructedpartially of relatively flexible materials and partially of relativelystiff materials. Further still, it may be desirable for push rod (630)to be constructed of a relatively stiff material that may also be bentlaterally. One exemplary material may comprise a shape memory material,such as nitinol. It should be understood that while the presentdisclosure describes the deployment of a biopsy site marker (650), otheritems may be used with marker deployment tool (600), including, but notlimited to, radioactive dyes or items, medicinal items (liquid,semi-solid, or solid), and/or any other item. Other various versions andadaptations for marker deployment tool (600) will be apparent to one ofordinary skill in the art in view of the teachings herein.

A. Exemplary Scalloped Tip

In some situations, manufacturing variations create push rods of markerdeployment tools of differing sizes. On occasions where the push rod isslightly longer than expected, the push rod may be redirected by theramp at the distal end of the cannula and protrude out the lateraldeployment aperture when the plunger is completely depressed. While thismay not necessarily be an issue for some users, on occasion, a userutilizing a marker deployment tool may continue to depress the plungerwhile removing the marker deployment tool from within the biopsy device.If the push rod is still extended out the lateral deployment aperture,the biopsy device's lateral aperture and/or tubular cutter may sever aportion of the push rod when the user is removing the marker deploymenttool. Accordingly, it may be useful to provide a way of limiting thetendency for the push rod to protrude out of the lateral deploymentaperture, thereby reducing the likelihood of severing the push rod, or,at least decreasing the size of any portion of the push rod that issevered.

Referring to FIGS. 10-11, a scalloped tip (700) is coupled to distal end(612) of cannula (610). Scalloped tip (700) can be a molded or castcomponent, and scalloped tip (700) may comprise a distal tip (714), aramp (710) having a ramp surface (712), and a marker engaging element(720). Ramp surface (712) aids in directing biopsy marker (650) frominside marker cannula (610) through lateral deployment aperture (620).Marker engaging element (720) may optionally be employed to retainbiopsy marker (650) in marker cannula (610) until the user intends todeploy biopsy marker (650). Marker engaging element (720) of the presentexample is disposed within marker cannula (610) and extends along aportion of marker cannula (610) opposite to lateral deployment aperture(620) such that marker engaging element (720) reinforces the portion ofmarker cannula (610) where lateral deployment aperture (620) is formed.One merely exemplary benefit to this arrangement is that marker engagingelement (720) can help to stiffen marker cannula (610) in the regionwhere the wall of marker cannula (610) is cut to form lateral deploymentaperture (620). As shown in FIG. 11, marker engaging element (720)extends from the proximal most portion of ramp surface (712), but doesnot extend proximally of the proximal-most end of lateral deploymentaperture (620), though it should be understood that in other embodimentsa portion of marker engaging element (720) may extend proximally oflateral deployment aperture (620). Marker engaging element (720) alsocomprises a tapered proximal end (722) to aid in urging biopsy marker(650) out through lateral deployment aperture (620). In one merelyexemplary version, marker engaging element (720) has tapered proximalend (722) having a first incident angle of approximately 30 degrees andramp (710) has a second incident angle of approximately 45 degrees.

Scalloped tip (700) of the present example further comprises a push rodrecess (730) extending proximally from ramp surface (712). Push rodrecess (730) is configured to be able to at least partially receive thedistal end of push rod (630) when plunger (644) is depressed, though itshould be understood that push rod (630) is not required to beinsertable into push rod recess (730). In the example shown in FIG. 11,push rod recess (730) comprises a hemicylindrical longitudinal recessextending from ramp (710) such that ramp surface (712) comprises aU-shaped surface for biopsy marker (650) to be deflected off of and intothe biopsy site. The longitudinal length of push rod recess (730) may bedetermined such that the varying-length push rods (630) resulting fromvariations during manufacturing will fit within push rod recess (730).One merely exemplary longitudinal length for push rod recess (730) maybe approximately 0.26 inches. Push rod recess (730) may also have avertical depth between approximately 0.03 and 0.052 inches. Furthermore,push rod (630) and push rod recess (730) may be configured to have asmaller diameter than marker cannula (610) and marker (650) such thatmarker (650) does not enter push rod recess (730). Of course otherequally suitable dimensioning will be apparent to one of ordinary skillin the art in view of the teachings herein.

In the arrangement shown in FIGS. 10-11, when push rod (630) is distallyactuated by the user depressing plunger (644), push rod (630) slidesbiopsy marker (650) distally within marker cannula (610). When biopsymarker (650) encounters marker engaging element (720), marker (650) isdeflected to exit through lateral deployment aperture (620). As push rod(630) and marker (650) advance further distally, marker (650) is furtherguided out of lateral deployment aperture (620) by ramp surface (712).As push rod (630) continues to advance distally to ensure that biopsymarker (650) is deployed, push rod (630) slightly deflects off of rampsurface (712) and enters push rod recess (730). When plunger (644) isfully depressed, push rod (630) of the present example may be located atleast partially within push rod recess (730), though push rod (630) mayalternatively not enter push rod recess (730). Thus, even if a usercontinues to depress plunger (644) while removing marker deployment tool(600), only a little, if any, of push rod (630) protrudes from lateraldeployment aperture (620). As will be appreciated by one of ordinaryskill in the art in view of the teachings herein, when the user isremoving marker deployment tool (600), push rod recess (730) decreasesthe possibility of a portion of push rod (630) being severed by lateralaperture (46) or tubular cutter (90) of biopsy device (10).

It should be understood, however, that push rod recess (730) may beconfigured in other ways as well. For instance, push rod recess (730)may be an enclosed recess within scalloped tip (700) located belowlateral deployment aperture (620) such that push rod (630), if it enterspush rod recess (730), does not protrude out lateral deployment aperture(620). Instead, push rod (630) enters the enclosed recess. One suchconfiguration for this enclosed cylindrical recess may be ahemicylindrical recess in marker engaging element (720) and an enclosedcylindrical recess in ramp (710). Other configurations may includevarious geometrically shaped recesses to accommodate a wide variety ofpush rod configurations. Furthermore, scalloped tip (700) may comprise aradiopaque marker embedded within scalloped tip (700) or scalloped tip(700) may be made of a radiopaque material to aid in imaging markerdeployment tool (600) while deploying marker (650). Further still,scalloped tip (700) may comprise other suitable materials to be viewablethrough other equally suitable imaging techniques. Of course scallopedtip (700) may be configured in any other suitable fashion as will beapparent to one of ordinary skill in view of the teachings herein.

B. Exemplary Alternative Scalloped Tip

One merely exemplary alternative scalloped tip (750) is shown in FIG.12. Alternative scalloped tip (750) can also be a molded or castcomponent, and alternative scalloped tip (750) of the present examplecomprises a distal tip (752), a ramp (760) having a ramp surface (762),and a marker engaging element (770). Ramp surface (762) aids indirecting biopsy marker (650) from inside marker cannula (610) throughexemplary alternative lateral deployment aperture (790). Marker engagingelement (770) may optionally be employed to retain biopsy marker (650)in marker cannula (610) until the user intends to deploy biopsy marker(650), shown in FIG. 10. Marker engaging element (770) of the presentexample is disposed within marker cannula (610) and extends along aportion of marker cannula (610) opposite to lateral deployment aperture(790) such that marker engaging element (770) reinforces the portion ofmarker cannula (610) where lateral deployment aperture (790) is formed.One merely exemplary benefit to this arrangement is that marker engagingelement (770) may help to stiffen marker cannula (610) in the regionwhere the wall of marker cannula (610) is cut to form lateral deploymentaperture (790). As shown in FIG. 12, marker engaging element (770)extends from the proximal most portion of ramp surface (762), but doesnot extend proximally of the proximal-most end of lateral deploymentaperture (790), though it should be understood that in other embodimentsa portion of marker engaging element (770) may extend proximally oflateral deployment aperture (790). Marker engaging element (770) alsocomprises a tapered proximal end (772) to aid in urging biopsy marker(650) out through lateral deployment aperture (790). In one merelyexemplary configuration, marker engaging element (770) has taperedproximal end (772) having a first incident angle of approximately 30degrees and ramp (760) has a second incident angle of approximately 45degrees.

Alternative scalloped tip (750) of the present example further comprisesa push rod recess (780) extending proximally from ramp surface (762).Push rod recess (780) is configured to be able to at least partiallyreceive the distal end of push rod (630) when plunger (644) isdepressed, though it should be understood that push rod (630) is notrequired to be insertable into push rod recess (780). In the exampleshown in FIG. 12, push rod recess (780) comprises a hemicylindricallongitudinal recess extending from ramp (760) such that ramp surface(762) comprises a U-shaped surface for biopsy marker (650) to bedeflected off of and into the biopsy site. The longitudinal length ofpush rod recess (780) may be determined such that the varying-lengthpush rods (630) resulting from variations during manufacturing will fitwithin push rod recess (780). Push rod recess (780) of the presentexample further comprises a distal ramp (782). Distal ramp (782)terminates at the distal end of lateral deployment aperture (790) andextends proximally into push rod recess (780). In one merely exemplaryversion, distal ramp (782) extends from the distal end of lateraldeployment aperture (790) to a point approximately half the distancebetween the proximal end of push rod recess (780) and the distal end oflateral deployment aperture (790). Of course, distal ramp (782) mayextend proximally to ramp (760) or to any other suitable locationbetween ramp (760) and the distal end of lateral deployment aperture(790). Distal ramp (782) of the present example may further aid in thedeployment of biopsy marker (650) by reducing the likelihood that biopsymarker (650) will catch upon the distal end of lateral deploymentaperture (790). Push rod (630) and push rod recess (780) may also beconfigured to have a smaller diameter than marker cannula (610) andmarker (650) such that marker (650) does not enter push rod recess(780). Of course other equally suitable dimensioning will be apparent toone of ordinary skill in the art in view of the teachings herein.

Similar to the arrangement shown in FIGS. 10-11, when biopsy marker(650) encounters marker engaging element (770) of the example shown inFIG. 12, marker (650) is deflected to exit through lateral deploymentaperture (790). As push rod (630) and marker (650) advance furtherdistally, marker (650) is further guided out of lateral deploymentaperture (790) by ramp surface (762). As push rod (630) continues toadvance distally to ensure that biopsy marker (650) is deployed, pushrod (630) slightly deflects off of ramp surface (762) and enters pushrod recess (780). Biopsy marker (650) may further deflect off of distalramp (782). When plunger (644) is fully depressed, push rod (630) may belocated at least partially within push rod recess (780), though push rod(630) may alternatively not enter push rod recess (780). In the exampleshown in FIG. 12, some push rods (630) may deflect off of distal ramp(782). Such deflection may further aid in the deployment of biopsymarker (650) out of lateral marker aperture (790). Similar to the markerdeployment tool (600) of FIGS. 10-11, only a little, if any, of push rod(630) protrudes from lateral deployment aperture (790) in the presentexample. As will be appreciated by one of ordinary skill in the art inview of the teachings herein, when the user is removing markerdeployment tool (600), push rod recess (780) decreases the possibilityof a portion of push rod (630) being severed by lateral aperture (46) ortubular cutter (90) of biopsy device (10).

C. Magnetic Marker Deployment Tool Tip

While access to the patient's tissue or a cavity in the tissue may beprovided through an access chamber in the tissue sample holder, in someinstances the lateral aperture of the needle is located at a longdistance from the access chamber. In such instances, if a marker is tobe deployed into the tissue, a lengthy marker deployment tool may needto be used to reach the lateral aperture. Moreover, with small sizedneedles, the marker deployment tool may also be required to be a slenderrod. In certain situations where the marker deployment tool is arelatively flexible tool, aligning the end of the marker deployment toolwith the access chamber may become a difficult task due to the lengthand flexing of the tool. Accordingly, it may be desirable to have somemethod of assisting the user to guide the tip of the marker deploymenttool to the access chamber.

An alternative marker deployment tool (800) is shown in FIG. 13. Markerdeployment tool (800) comprises a marker cannula (810), a biopsy sitemarker (850) slidably disposed within marker cannula (810), and a pushrod (830) having a distal end located proximal of biopsy site marker(850). In the present example, marker cannula (810) has a distal end(812) and a lateral deployment aperture (820), though it should beunderstood that these features are merely optional. For instance, markercannula (810) may have a blunt open distal end, a sharp open distal end,a valved end, or any other suitable configuration for marker cannula(610). Push rod (830) is also slidably disposed in marker cannula (810)and is operable to push biopsy site marker (850) out through the lateraldeployment aperture (820), as shown in FIG. 13. A grip may be coupled tomarker cannula (810) and a plunger may be coupled to push rod (830) suchthat marker deployment tool (800) may be manipulated by a single hand ofa user to deploy biopsy site marker (850). For marker deployment tools(800) having a lateral deployment aperture (820), a ramp-like structure,such as the scalloped tips (700, 750) described above, may be providedat or near the distal end of marker cannula (810) to redirect biopsysite marker (850) out lateral deployment aperture (820). In instanceswhere a relatively flexible marker deployment tool (800) is necessary,marker cannula (810) and push rod (830) may be constructed of relativelyflexible materials. Alternatively, it may be desirable for push rod(830) to be constructed of a relatively stiff material that may also bebent laterally. An exemplary material may comprise a shape memorymaterial, such as nitinol. In yet other versions, push rod (830) maycomprise a proximal portion and a distal portion. Proximal portion ofpush rod (830) may comprise a relatively stiff material while the distalportion comprises a relatively flexible material. Alternatively, theproximal portion may comprise a relatively flexible material while thedistal portion comprises a relatively stiff material. Still othervarious versions and adaptations for marker deployment tool (800) willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

Marker deployment tool (800) of the present example further comprises amagnet (860) disposed at or near the distal end of cannula (810). Magnet(860) may be a ferrous magnet, a neodymium magnet, a samarium-cobaltmagnet, or any other suitable magnet (860) as will be apparent to one ofordinary skill in the art in view of the teachings herein. In oneexemplary version, magnet (860) is embedded in distal end (812).Alternatively, magnet (860) may be adhesively attached to distal end(812). In yet a further version, magnet (860) may be embedded oradhesively coupled to marker cannula (810). Magnet (860) may also be anysuitable shape, such as a sphere, disk, cylinder, bar, or any othershape. In a further version, magnet (860) may comprise a powder or aplurality of magnets that may impregnated in distal end (812). Stillother equally suitable configurations for magnet (860) and markerdeployment tool (800) will be apparent to one of ordinary skill in theart in view of the teachings herein.

A complementary magnet or magnets (900) are coupled to biopsy device(10). In one merely exemplary version shown in FIG. 14, thecomplementary magnets (900) may be located within rotatable manifold(140) and affixed near access chamber (160) of tissue sample holder(100), as described above. Specifically, a plurality of magnets (900)are affixed and arranged around the proximal opening of access chamber(160). In one merely exemplary version, six magnets (900) may bearranged around access chamber (160) such that access chamber (160) isthe center of the ring of six magnets (900). Alternatively, an annularmagnet may be used instead of a plurality of magnets. As one of ordinaryskill in the art will appreciate, the ring of magnets (900) form amagnetic field that can attract magnet (860) in marker deployment tool(800) towards the ring. Alternatively, marker deployment tool (800) maycomprise a magnetically attractable metal member positioned withindistal end (812) of marker deployment tool (800) such that the ring ofmagnets (900) attracts the distal end (812). This magneticallyattractable metal may comprise a powder or a plurality of metalcomponents, such as small orbs, that may be impregnated in the distalend (812). Further still, if marker deployment tool (800) comprises ametallic marker cannula (810), then marker cannula (810) may beattracted to magnets (900). Yet a further version may include omittingmagnets (900) and replacing magnets (900) with a magneticallyattractable metallic annular member such that magnet (860) of markerdeployment tool (800) may be attracted to the annular member. In theexample shown in FIGS. 13-14, when a user may be attempting to align thetip of marker deployment tool (800), magnet (860) and magnets (900)cooperatively assist the user by magnetically guiding the tip of markerdeployment tool (800) toward the opening of access chamber (160). Thus,a user may be able to single-handedly insert marker deployment tool(800) into the opening of access chamber (160) without having to grip oradjust the end of marker deployment tool (800). Still other equallysuitable configurations for ring of magnets (900), magnet (860), accesschamber (160), and marker deployment tool (800) will be apparent to oneof ordinary skill in the art in view of the teachings herein.

While the foregoing discussion has described the complementary magnets(900) as being implemented near access chamber (160) of tissue sampleholder (100), magnets (900) may be arranged at other equally suitableareas on biopsy device. For instance, in a biopsy device having a sideopening for insertion of a marker deployment tool, magnets (900) may beaffixed, embedded, or coupled near or around this side opening.Likewise, for a biopsy device without a proximal tissue sample holder,magnets (900) may be affixed, embedded, or coupled to a tubular cutter,such as tubular cutter (90) described above. In an alternative version,the ring of magnets (900) may be located adjacent to transfer member(22) such that marker deployment tool (800) may be attracted to the ringof magnets (900) when tissue sample holder (100) is removed. In such aversion, the ring of magnets (900) may be located proximally of transfermember (22) or distally within transfer member (22). In the versionhaving the ring of magnets (900) located distally within the transfermember (22), a funnel (not shown), may be provided to possibly aid inguiding marker deployment tool (800). Further still, the ring of magnets(900) may be impregnated within a portion casing (80) near transfermember (22) or tubular cutter (90). Magnets (900) may be configured forany other suitable location on a biopsy device to facilitate theguidance of marker deployment tool (800) for use in deploying markerswithin a patient's body as will be apparent to one of ordinary skill inthe art in view of the teachings herein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. A biopsy device, the biopsy device comprising: (a) a probeassembly, wherein the probe assembly includes: (i) a needle, and (ii) acutter, wherein the cutter is movable relative to the needle to sever atissue sample; and (b) a tissue sample holder coupled with the probeassembly, wherein the tissue sample holder comprises: (i) an outercover, (ii) a rotatable manifold received by the outer cover, whereinthe rotatable manifold defines a plurality of chambers, and (iv) aplurality of trays, wherein each tray of the plurality of trays isinsertable into a corresponding chamber of the plurality of chambers ofthe rotatable manifold, wherein each tray of the plurality of trayscomprises: (A) a base, (B) a proximal wall, (C) a distal wall, (D) apair of sidewalls extending between the proximal wall and the distalwall, and (E) at least one offset member, wherein the at least oneoffset member of each tray extends laterally from each tray to seal eachchamber of the plurality of chambers relative to each tray.
 2. Thebiopsy device of claim 1, wherein the at least one offset member of eachtray comprises a wiper seal that is configured to sealingly engage aninterior portion of a corresponding chamber of the plurality ofchambers.
 3. The biopsy device of claim 1, wherein the at least oneoffset member is positioned to offset the proximal wall of each tray ofthe plurality of trays from a main portion of each tray.
 4. The biopsydevice of claim 1, wherein the base comprises a plurality of openings.5. The biopsy device of claim 4, wherein the openings are disposeddistally of the at least one offset member.
 6. The biopsy device ofclaim 1, wherein the base, the distal wall, the at least one offsetmember and the pair of sidewalls of each tray of the plurality of traysdefine a tissue receiving chamber.
 7. The biopsy device of claim 6,wherein the tissue receiving chamber is configured to receive a singletissue sample.
 8. The biopsy device of claim 1, wherein at least oneoffset member comprises a pair of offset members.
 9. The biopsy deviceof claim 1, wherein the proximal wall of each tray of the plurality oftrays is connected to at least one other tray such that at least some ofthe trays of the plurality of trays are interconnected.
 10. A tissuesample holder for use with a biopsy device, the tissue sample holdercomprising: (a) a rotatable manifold, wherein the rotatable manifoldcomprises a plurality of chambers, wherein each chamber of the pluralityof chambers is configured to receive a tissue sample from the cutter ofthe biopsy device, and (b) at least one tissue sample receiving traycarried by the rotatable manifold and removable from the rotatablemanifold, wherein the at least one tissue sample receiving traycomprises: (i) a distal wall, wherein the distal wall includes anopening configured to receive tissue samples therethrough, (ii) aproximal wall, (iii) a floor extending longitudinally between the distalwall and the proximal wall, and (iv) a pair of sidewalls extendinglongitudinally between the distal wall and the proximal wall, and (v) anintermediate member, wherein the intermediate member is disposeddistally of the proximal wall, wherein a sealing portion of theintermediate member extends outwardly from the floor and the pair ofsidewalls, wherein the sealing portion is configured to seal against aportion of the rotatable manifold when the at least one tissue samplereceiving member is carried by the rotatable manifold.